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临床试验/CTRI/2020/10/028716
CTRI/2020/10/028716已完成不适用

Comparison of the effect of intraoperative fluids (plasmalyte vs sterofundin) during major oncological surgeries.

Rajiv Gandhi cancer institute1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年1月11日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
pH and lactate levels in ABG

研究概览

简要总结

Iv fluid is administered intra-operatively to maintain fluid and electrolyte haemostasis. This facilitates optimum tissue oxygen delivery. As serum lactate is a biomarker of severe tissue hypoperfusion, we compared the lactate levels at the end of surgery.

Plasmalyte and Sterofundin are balanced crystalloid solutions that are routinely used in our institute in intraoperative period. Till now there are very few studies comparing the effect of these two on perfusion or acid base status. However no study has been done in major surgeries.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • patients undergoing major onco-surgeries.

排除标准

  • patients with significant renal, cardiac, or liver impairment, electrolyte imbalance in preoperative evaluation.

结局指标

主要结局

pH and lactate levels in ABG

时间窗: At the start of surgery and at the time of haemostasis

次要结局

  • Heart rate, mean blood pressure, total amount of crystalloid required, colloid requirement, blood replaced,(Baseline, hourly intraoperatively till end of surgery)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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